The risk of adverse cardiovascular outcomes in patients hospitalized with acute coronary syndrome (ACS) is highest in elderly patients. Although recent clinical trials have shown that high-intensity statin therapy significantly reduces adverse cardiovascular events for patients with established coronary heart disease, its use in elderly individuals remains controversial. As such, recent lipid treatment guidelines do not advocate for the routine use of high-intensity therapy for patients older than 75 years. In this pre-specified secondary analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), outcomes were compared by age among 18,144 patients hospitalized for ACS and assigned to either simvastatin plus ezetimibe or simvastatin plus placebo. The primary endpoint was a composite of death due to a cardiovascular event, major adverse cardiac event (non-fatal MI, unstable angina leading to hospitalization, coronary revascularization after day 30), or nonfatal stroke. At randomization, 56.1% of patients were less than 65 years old, 28.5% were 65 to 74 years old, and 15.4% were 75 years or older. Researchers found that patients of all ages in the simvastatin-ezetimibe group had lower rates of the primary endpoint than those in the simvastatin-placebo group, with the greatest absolute risk reduction (8.7%) occurring in patients 75 years or older (less than 65 years of age: 29.9% vs. 30.8% respectively, absolute risk reduction 0.9%, HR 0.97, 95% CI 0.90 to 1.05; 65 to 74 years of age, 35.1% vs. 35.9% respectively, absolute risk reduction 0.8%, HR 0.96, 95% CI 0.87 to 1.0; 75 years of age or older: 38.9% vs. 47.6% respectively, absolute risk reduction 8.7%, HR 0.80, 95% CI 0.70 to 0.90). The number needed to treat to prevent one primary end point event by treatment with simvastatin-ezetimibe was 125 (95% CI 113 to infinity) among patients younger than 75 and 11 (95% CI 8 to 23) among patients 75 years or older. The rate of adverse events did not increase with age or with simvastatin-ezetimibe therapy as compared to simvastatin-placebo. In summary, this study suggests that the use of high-intensity therapy with simvastatin-ezetimibe to lower lipid levels in patients 75 years or older after ACS is well-tolerated and may improve clinical outcomes as compared to simvastatin monotherapy.
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